Application 211843
- Type
- NDA
- Sponsor
- MISSION PHARMACAL CO
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | THIOLA EC | TIOPRONIN | TABLET, DELAYED RELEASE;ORAL | 100MG | Yes | No |
| 002 | THIOLA EC | TIOPRONIN | TABLET, DELAYED RELEASE;ORAL | 300MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0178-0901 | Thiola EC | tiopronin | Mission Pharmacal Company | NDA | Current |
| 0178-0901 | Thiola EC | tiopronin | Mission Pharmacal Company | NDA | Current |
| 0178-0902 | Thiola EC | tiopronin | Mission Pharmacal Company | NDA | Current |
| 0178-0902 | Thiola EC | tiopronin | Mission Pharmacal Company | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 66731 | SUPPL | 2021-03-10 |
| 66677 | SUPPL | 2021-03-09 |
| 61493 | ORIG | 2020-01-02 |
| 59222 | ORIG | 2019-07-02 |
| 59200 | ORIG | 2019-07-01 |